BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BDRV CANN SCW SS P/T DIA4.5X60 MM

    MDR report key: 6384905 · Received March 7, 2017

    Report

    Report Number
    0009610576-2017-00008
    Event Type
    Injury
    Date Received
    March 7, 2017
    Report Date
    March 5, 2017
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    HWC
    PMA / PMN Number
    PK140891
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET US AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET IN (B)(4) MANUFACTURES A SIMILAR DEVICE IN THE UNITED STATES UNDER 510K NUMBER K140891. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 9610576-2017-00008 / 00009).

    Description of Event or Problem · 1

    PATIENT HAS ALLEGED AN ALLERGY TO THE CANNULATED TRAUMA SCREWS IMPLANTED DURING A FOOT OSTEOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167716 BDRV CANN SCW SS P/T DIA4.5X60 MM FASTENER, FIXATION HWC BIOMET SPAIN, S.L. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other